Akorn recalls 0.5% Timolol Maleate eye drops due to potential impurities at 12-month stability. Consumers with prescription vials from specific lot numbers should check if affected.
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Akorn is recalling prescription timolol eye drops that may contain an unknown impurity at the 12-month stability point. This could pose a risk to users, though the exact danger isn't specified in the recall notice.
The recall states an unknown impurity was identified at the 12-month stability point. This could potentially cause harm, but the exact risk isn't specified in the recall notice. The impurity might affect the eye drops' safety over time.
Prescription users of Akorn's Timolol Maleate Ophthalmic Solution 0.5% 5 x 0.3 mL vials with lot number 9N72 (expiring 09/30/2022) are affected. People using these eye drops for medical conditions are most at risk.
Check for the lot number 9N72 on the vial label, which expires September 30, 2022. The product is a prescription-only 0.5% Timolol Maleate Ophthalmic Solution in 5 single-dose vials.
Look for the lot number 9N72 on the vial label, which expires September 30, 2022.
The recall states an unknown impurity was found at the 12-month stability point, but the exact risk isn't specified. The product may not be safe for use.
The recall does not specify a remedy, so check the vial label for the lot number 9N72 and contact Akorn if you have concerns.
Check the vial label for the lot number 9N72 (expiring 09/30/2022) and the NDC number 17478-189-24.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-1471-2022 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1471-2022 from Akorn. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.